Wonjin Mulsan Co., Ltd.: FDA clearances and approvals
Wonjin Mulsan Co., Ltd. has 5 FDA 510(k) clearances (first 2009, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time: 140 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 115 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 250 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Wonjin Mulsan Co., Ltd.'s cleared 510(k)s took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | 5 | 5 |
Review panels
Most recent Wonjin Mulsan Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211283 | Compressible Limb and Circulation Therapy System, Model POWER-Q2300 | IRP | 2021-09-14 | 140 |
| K200660 | Compressible Limb and Circulation Therapy System | IRP | 2021-03-08 | 361 |
| K113275 | COMPRESSIBLE LIMB THERAPY SYSTEM | IRP | 2012-02-27 | 115 |
| K100656 | COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) | IRP | 2010-05-26 | 79 |
| K080134 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) | IRP | 2009-01-23 | 371 |
Recalls
openFDA lists no recalls under a recalling firm named Wonjin Mulsan Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Wonjin Mulsan Co., Ltd. have?
Wonjin Mulsan Co., Ltd. has 5 FDA 510(k) clearances (first 2009, latest 2021), across 1 product code in 1 review panel.
How long does FDA take to clear Wonjin Mulsan Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Wonjin Mulsan Co., Ltd.'s cleared 510(k)s is 140 days.
What devices does Wonjin Mulsan Co., Ltd. make?
Its most frequent FDA product codes are IRP (Massager, Powered Inflatable Tube, 5).
Has Wonjin Mulsan Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Wonjin Mulsan Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Wonjin Mulsan Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IRP, Wonjin Mulsan Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.